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posted: 6/17/2013 5:20 AM

Counterfeit drugs pose consumer risks, experts say

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By Cristin Severance

The prescription medicine you get online or from your pharmacy could be fake -- and harmful.

The World Health Organization estimates that 25 percent of drugs consumed in poor countries are counterfeit or substandard. Some international watchdog groups say up to 50 percent of treatments sold in the developing world are fraudulent.

Counterfeit estimates for the U.S. are much lower -- 1 percent to 2 percent of drugs are fake, according to the Food and Drug Administration and the National Association of Boards of Pharmacy. Industry experts assume that federal and state authorities' tighter controls over manufacturing, distribution and retail sale of prescription and over-the-counter drugs reduce the incidence of fraud.

But with more than 4 billion prescriptions filled in the United States each year -- worth an estimated $310 billion -- even 1 percent translates to 4 million packages that lack an active ingredient or have an insufficient amount, or that contain useless or even toxic fillers.

It's easy to trade in counterfeit drugs, a graduate student at the University of California, San Diego, demonstrated by setting up a fake pharmacy online. Called "No prescription drugs," it has a domain name, Facebook page, Twitter account and plenty of customers seeking counterfeit prescriptions.

"We were up and running in an hour," said Dr. Bryan Liang, a professor of anesthesiology at the University of California, San Diego, and director of the San Diego Center for Patient Safety. "We had an average of 100 hits a month ... from 12 countries."

Liang's graduate student set up the fake online site to gauge how easy it might be to push fake meds online. The site couldn't actually sell drugs; instead, it tracked the number of hits.

Liang, an expert on counterfeiting, said hundreds of sites sell fake drugs.

The Scripps Howard News Service recently reported that a 2009 crackdown by the Food and Drug Administration on unauthorized online pharmacies led to the seizure of more than 800 packages that included Viagra, the pain reliever Vicodin and antihistamines.

Some of the fake drugs had three times the level of active ingredient they should have, others none. Fillers included drywall, antifreeze and yellow highway line paint.

Liang, former FBI agents and drug experts met in San Diego in April at an annual conference focusing on counterfeit drugs.

Such drugs are potentially lethal, several industry experts told KGTV-TV.

In 2008, there were at least 149 deaths and many more severe allergic reactions to tainted blood thinner imported from China.

Drugs are made in other countries, in factories that aren't regulated by the FDA or any other oversight agency, Liang said. Officials have seized drugs that include ingredients banned in the U.S. for safety reasons.

Scripps reported that the FDA has issued warnings about substandard -- and illegal -- imported versions of the tumor-fighting drug Avastin three times in the past year, most recently shipments of a Turkish version of the drug.

Some counterfeit copies of drugs are impossible to detect without a laboratory test. But the National Association of Boards of Pharmacy offers several red flags for consumers concerned that the drug they've been given is not legitimate.

Watch out for:

• Packaging that appears to have been opened or labels that appear different from those seen in the past.

• Medicines that are cracked or chipped or have a different color or shape than you're used to.

• A medicine that has a different taste or texture than you've previously experienced.

• Adverse effects after taking the medicine -- side effects that you have not had before or that are not mentioned on warning labels.

If you suspect you have a fake drug, contact the FDA's Medwatch program (800) 332-1088 or your state pharmacy board. Or, report it to the manufacturer or to the pharmacy that dispensed the drug.

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